Kornimate/medical-research-clean huggingface dataset:
cardiovascular involvement in patients with granulomatosis with polyangiitis

Conditions: Granulomatosis With Polyangiitis; Atherosclerosis; Thrombosis

Summary: granulomatosis with polyangiitis (gpa) is one of antineutrophil cytoplasmic autoantibody (anca) - associated vasculitis. inflammation-induced thrombosis is considered to be a feature of systemic autoimmune diseases. gpa usually involves the upper and lower respiratory tract and renal systems, where necrotizing glomerulonephritis and pulmonary capillaritis are often detected. however, it may also affect other organ systems. cardiac involvement in gpa occurs in approximately 6% to 44% of cases and is secondary to necrotizing vasculitis with granulomatous infiltrates. cardiac involvement is an independent predictor of mortality in gpa patients. in this prospective cohort study, consecutive gpa patients who were hospitalized in the department of family medicine, internal and metabolic diseases at the medical university of warsaw in poland are included. in all patients echocardiography and laboratory tests are perform.

granulomatosis with polyangiitis (wegener's; gpa) is an antineutrophil cytoplasmic antibody (anca)-associated vasculitis (aav), which also includes microscopic polyangiitis and eosinophilic granulomatosis with polyangiitis (churg-strauss syndrome). gpa is characterized by granulomatous inflammation and necrotizing vasculitis predominantly affecting small- to medium-sized blood vessels and the presence of anca directed to specific antigens, particularly proteinase 3 (pr3-anca) and myeloperoxidase (mpo-anca). the destructive inflammatory processes of gpa have a predilection for the upper and lower airways and the kidneys, but any organs can be affected. an increased incidence of various cardiovascular events has been demonstrated among gpa patients. cardiac involvement is also an independent predictor of mortality in gpa patients. in this prospective cohort study, consecutive gpa patients who are hospitalized in the department of family medicine, internal and metabolic diseases at the medical university of warsaw in poland are included. all patients are diagnosed with gpa according to current guidelines. patients are entered into the study at the time point when a new diagnosis of gpa was established and received initial treatment at our centre. data collection included a full interim medical history, physical examination, laboratory studies and review of adverse events. additionally, in all patients an echocardiography is performed.

Eligibility criteria:
inclusion criteria: * newly diagnosed granulomatosis with polyangitis exclusion criteria: -

Keywords: granulomatosis with polyangitis, cardiac involvement
a study of viracept in aids patients with mycobacterium avium complex disease (mac)

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give viracept to aids patients who are being treated for mac.


Eligibility criteria:
inclusion criteria patients must have: * hiv infection * new diagnosis of mac bacteremia and \< 7 days of therapy. prior medication: allowed: patients no more than 7 days of therapy for mac disease. exclusion criteria prior medication: excluded: prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir.

Keywords: aids-related opportunistic infections placebos mycobacterium avium-intracellulare infection acquired immunodeficiency syndrome hiv protease inhibitors nelfinavir anti-infective agents anti-hiv agents
tl011 in severe, active rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine the safety and pharmacology of tl011 in patients with severe rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * adult subjects * rheumatoid arthritis as defined by the 1987 acr classification * severe active seropositive disease * inadequate response or intolerance to other dmards * treatment with mtx exclusion criteria: * rheumatic autoimmune disease other than ra * active infection * known immunodeficiency syndrome * positive hepatitis b surface antigen or antibodies to hepatitis c * history of cancer
study about the response to the administration of a third dose of mrna-1273 vaccine (covid-19 vaccine moderna) in renal transplants with immunological failure initial to vaccination

Conditions: Covid19

Summary: the objective will be to analyze the development of cellular and humoral immunity against sars-cov-2 after administration of a third dose of mrna-1273 (moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years; 2. male or female sex; 3. renal transplant with stable renal function in the last 2 months prior to study inclusion. 4. had received a full schedule of vaccination for sars-cov-2 with mrna1273 vaccine (moderna) and remained seronegative at 2 weeks after the second dose. 5. patient giving written informed consent. exclusion criteria: 1. renal transplantation \< 3 months; 2. pregnancy or lactation status; 3. rejection treated within the last 6 months; 4. presence of humoral immunity to sars-cov-2 defined as the presence of specific igm/igg.

Keywords: vaccine
effects of melatonin in pcos women

Conditions: Polycystic Ovary Syndrome

Summary: the aim of our study is to investigate the effects of a treatment with melatonin on clinical, endocrine and metabolic features in women affected by pcos. the study group included 40 patients treatend with 2 mg of melatonin daily for six months. menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian volume and antral follicular count, an oral glucose tollerance test and hormonal assays are evaluated before and after therapy.


Eligibility criteria:
inclusion criteria: * women with pcos in accordance with rotterdam criteria exclusion criteria: * pregnancy * past history of cardiovascular diseases * diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test) * hypertension * significant liver or renal impairment * other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal) * neoplasms
electrochemotherapy for non-curable gastric cancer

Conditions: Gastric Cancer

Summary: this is an explorative, phase i clinical trial. the aim of this study is to establish the safety and efficacy of electrochemotherapy for non-curable gastric cancer.

this is an explorative, phase i clinical trial. aim of this study is to establish the safety of electrochemotherapy as a palliative treatment for advanced (non-curable) gastric cancer. the study involves recruitment of 8 patients with histologically verified and non-curable gastric cancer (including siewert type ii and ii). patients will be recruited from department of surgery, odense university hospital and from zealand university hospital after their case has been reviewed by the multidisciplinary team (mdt). electrochemotherapy will take place at department of surgery, zealand university hospital. after the treatment patients will be referred to odense university hospital for follow-up. electrochemotherapy will be performed as an additive treatment to standard oncological care. patients are treated once and will be followed with endoscopy, biopsies, scans, blood samples and questionnaires after 4-6 weeks and 8-12 weeks with a minimum interval of 4 weeks.

Eligibility criteria:
inclusion criteria: * patients must be mentally capable of understanding the information given. * patients must give written informed consent. * histologically verified gastric cancer (adenocarcinoma, including siewert type ii and ii) * non-curable disease according to mdt decision * age ≥ 18 years. * asa class i-iii (classification of the american society of anesthesiology) * thrombocytes ≥ 50 billions/l, inr \>1,2. medical correction is allowed, e.g. correction of elevated inr by means of vitamin k or administration of freshly frozen plasma. * performance status ecog/who ≤2 exclusion criteria: * locally advanced non-metastatic egj/gc patients that may become resectable after pretreatment * inability to perform upper endoscopy with attached equipment. * uncorrectable coagulation disorder * patients with icd or pacemaker units * myocardial insufficiency, defined as nyha class \>2 * concurrent treatment with an investigational medicinal product. * renal impairment, defined as gfr \<40 ml/min * pregnancy * concurrent inclusion in a medical trial where the intervention may affect safety measures used in the current protocol. * patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments. * acute pulmonary infection. * medical history of severe pulmonary disease. * previous allergic reactions to bleomycin. * previous cumulative dose of bleomycin exceeding 250mg/m2.

Keywords: electrochemotherapy palliative treatment
hypertrophic scarring after facial burn

Conditions: Burn

Summary: subjects with a burn to the face and/or neck will be enrolled into the study and a three-dimensional scanner used to see if it can objectively measure scar color and volume and measure the effect of scar on motion of the face and neck.

subjects will have 11 clinic visits over a 2-year period. an initial scan of the subject's head and neck will be made. ten reproducible landmarks on the face and neck will be determined. the subject will return for follow up scans at day 14, day 28 and month 2,6,9,12,18 and 24.

Eligibility criteria:
inclusion criteria: * face and/or neck burn
study with rituximab, cyclophosphamide, doxorubicin liposomal (myocet®), vincristine, prednisone, (r-comp) to treat non-hodgkin's lymphoma

Conditions: Diffuse Large B-Cell Lymphoma

Summary: this is a multicenter study phase ii, open-label for cardiopathic patients affected by non-hodgkin's lymphoma diffuse large b cell cd20 + grade iiib follicular. the purpose is to study the feasibility of r-comp in this cohort of patients.


Eligibility criteria:
inclusion criteria: * nhl histological diagnosis of diffuse large b cell cd20 + (de novo or shift from low-grade nhl if not pretreated), grade iiib follicular nhl; * age \>= 18 years; * presence of at least 1 factor that defines the cardiopathy; * life expectancy \> 3 months; * in the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy; * written informed consent. exclusion criteria: * histology different from nhl diffuse large cell cd20 + or follicular iiib * age \< 18 years * inability to sign informed consent; * hiv positivity; * patients hbsag positive; * ast/alt \> 2 times the standard; * bilirubin \> 2 times the standard; * creatinine \> 2.5 mg / dl; * location of cns disease; * pregnancy ongoing; * damage to that organ or medical problems that could interfere with the therapy; * current uncontrolled infection; * senile dementia

Keywords: diffuse large b-cell lymphoma
comparison of efficacy between two myopia control lenses

Conditions: Myopia

Summary: this is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression.

the clinical trial aims to assess the safety and efficacy of a test lens, designed to modify the amount of myopic control signal on the retina without compromising vision. the primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.

Eligibility criteria:
inclusion criteria: * volunteer subject and guardian, fluent english spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form. * equal to or greater than 6 years and not older than 11 years at time of informed consent and assent. * spherical equivalent refractive error (ser) by manifest refraction between -0.50 and -4.75 d in each eye. * astigmatism, if present, of not more than 2.00 d. * difference in ser between the two eyes (anisometropia) by manifest refraction not more than 1.00 d. * best corrected visual acuity in each eye better than +0.20 logmar * agree to wear study spectacles for at least 10 hours a day and 6 days a week * willingness and ability to participate in trial for 1 year * willingness and ability to attend scheduled visits * not to involve concurrently in other myopia control treatments exclusion criteria: * history or presence of an ocular disease, strabismus, amblyopia * undergoing any myopia control intervention specifically atropine and orthokeratology * history of myopia control intervention specifically atropine, orthokeratology

Keywords: refractive errors eye diseases axial length myopia control
regenafil versus demineralized freeze dried bone allograft (dfdba) for periodontal defects

Conditions: Periodontal Diseases

Summary: the purpose of this research study was to determine whether treatment with the bone grafting material regenafil was as effective as the standard treatment using demineralized freeze dried bone allograft (dfdba). regenafil is demineralized freeze dried bone in a special gel form.

to compare the regenerative effects of a demineralized freeze dried bone allograft (dfdba) particulate in a biologic thermoplastic carrier (regenafil) to the standard of care. to compare the regenerative effects of a demineralized freeze dried bone allograft (dfdba) particulate in the treatment of intraosseous vertical defects following six months of healing. this was accomplished by evaluating clinical parameters including probing depth, attachment level and bleeding upon probing, using attachment level as the primary outcome variable. treatment of the vertical osseous defect is a challenging problem in periodontics. there are many treatment options including: 1. open flap debridement; 2. osseous graft alone; 3. membrane alone; 4. or membrane plus an osseous graft. choice of treatment may depend on the defect depth and configuration. a shallow, narrow 3 wall defect may respond well to open flap debridement while a deep 2 wall defect may need regenerative therapy such as an osseous graft, a membrane or combined membrane and graft treatment. studies of vertical defect therapy with defects about 4 mm or greater show that similar percent defect fill results are obtained with regenerative therapies. open flap debridement produces substantially less percent defect fill.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent prior to their participation. 2. be an adult age 18 and older. 3. have at least a 4 mm open vertical osseous defect depth on one tooth, visible on a radiograph and with a probing depth ≥ 5 mm. 4. have osseous defects that are either wide 3-wall, or combination defects. exclusion criteria: 1. have debilitating systemic diseases, or diseases that affect the periodontium. 2. have a known allergy to any of the materials that will be used in the study: * non-steroidal anti-inflammatory drugs (nsaids) * chlorhexidine digluconate * doxycycline * gelatin 3. need prophylactic antibiotics. 4. have a vertical osseous defect that is related to a furcation area. 5. smoke more than 1 pack per day. 6. have endodontically treated teeth or endodontic lesions at study sites. 7. have 1-wall defects. 8. have poor oral hygiene. 9. have anterior fillings (note: if a subject presents with anterior fillings, it will be at the discretion of the principal investigator as to whether they should be accepted into the study.) 10. be pregnant as evidenced by a positive urine pregnancy test taken at both the screening and baseline visits.

Keywords: periodontal treatment of intraosseous vertical defects
chimeric antigen receptor t-cell and cellular therapies for the treatment of cancer or blood diseases: evaluation of reporting of adverse events

Conditions: Adverse Drug Reactions; Cancer

Summary: car-t cells and cellular therapies may lead to various adverse reactions. this study investigates reports of different toxicities for cellular therapies in the world health organization's (who) global database of individual safety case reports (vigibase).

car-t cells and cellular therapies are responsible of a wide range of side effects.the investigators use vigibase, the world health organization (who) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with cellular therapies

Eligibility criteria:
inclusion criteria: * case reported in the world health organization (who) database of individual safety case reports to 01/01/2020 * adverse events reported were including any meddra terms * patients treated with cellular therapies reported in the who database. exclusion criteria: * chronology not compatible between the drug and the toxicity

Keywords: car-t cell cellular therapies
platelet rich plasma versus corticosteroids in knee osteoarthritis pain

Conditions: Knee Osteoarthritis (OA)

Summary: prospective, multi-center, randomized trial comparing platelet rich plasma (prp) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. the purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

platelet rich plasma has become increasingly utilized as a treatment option for knee osteoarthritis. corticosteroids is currently an approved medication to treat the symptoms of the knee osteoarthritis. there is limited evidence in a prospective randomized manner powered adequately to determine a difference between these treatments for pain associated with knee osteoarthritis. prospective, multi-center, single blind (participant), randomized trial comparing platelet rich plasma (prp) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. the purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, aged 21-80 years * radiographic diagnosis of kellgren-lawrence (kl) grade of ii or iii knee osteoarthritis * indicated for a knee injection to treat knee oa symptoms exclusion criteria: * any injections into the target knee within three months * current overlying skin infection * current or previous diagnosis of "chronic pain" * opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.) * allergy to any potential ingredients or medications utilized in any of the two groups * treatment with another investigational drug or other intervention for pain * diagnosis of diabetes mellitus * if female, pregnant or planning to be pregnant within the following 3 months or study duration * any condition(s) or diagnosis, both physical or psychological, or physical exam finding in the opinion of the investigator that would precludes participation

Keywords: platelet rich plasma knee oa prp corticosteroids osteoarthritis knee osteoarthritis
clinical evaluation of the modified laterally stretched technique (rt2) gingival recession vs tunneling with ct grafting

Conditions: Gingival Recession

Summary: regression analysis in a recent systematic review showed significantly greater mrc and crc values when modifications are done to the tun procedure to achieve more coronal advancement of the flap, coronal advancement also helps in covering the underlying graft for better recession coverage outcomes (tavelli et al., 2018), limited data is present on the possible influence of a covered or partially uncovered graft. however, it has been suggested that minimal exposure of the ctg may aid not only in achieving crc but also a harmonious gingival margin (john et al., 2015; rasperini et al., 2011).


Eligibility criteria:
* single or multiple rt2 gingival recession site/sites in the lower anterior teeth. * age \>/= 18 years. * patients with healthy or treated periodontal conditions. * patients willing to participate in the study. * absence of uncontrolled medical conditions. * full mouth plaque score \</= 20% (o'leary 1972). * full mouth bleeding score \<20% (ainamo and bay 1975). * patients with aesthetic concerns. exclusion criteria: * pregnant or lactating females. * deep recession sites more than 5 mm * tobacco smoking. * uncontrolled medical conditions. * uncooperative patients or unable to complete the study. * patients treated with any medication known to cause gingival hyperplasia. * no occlusal interferences.
brain imaging: cocaine effects & medication development - 5

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to define temporal profile of brain activation (rcbf) using xenon-spect and o 15-pet.


Eligibility criteria:
please contact site for information.

Keywords: cocaine
impact of y90 radiation segmentectomy on hcc

Conditions: Hepatocellular Carcinoma

Summary: the aim of this pilot study is to assess the efficacy of radiation segmentectomy with theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for thermal ablation as per the bclc guidelines, but are unable to receive thermal ablation due to unfavorable location of target lesions.


Eligibility criteria:
inclusion criteria: * age greater than 18 years, regardless of race or gender * hepatocellular carcinoma confirmed by histology for non-cirrhotic patients or non-invasive criteria according to aasld for cirrhotic patients * child-pugh class a or b7 without ascites * single tumor nodule ≤ 3 cm with a maximum distance of 5 mm from portal vein, hepatic vein, inferior vena cava, diaphragm, heart, stomach, bowel, liver capsule, gallbladder, bile duct * no prior locoregional treatment or external beam therapy of current hcc (recurrent hcc after resection may be included) * no confirmed extrahepatic metastases * no evidence of macrovascular invasion * ecog 0 * albumin \> 3.0 g/dl * plt ≥ 40 x103/μl * wbc ≥ 1.5 x103/μl * ast/alt ≤ 5 times the upper limit of normal (u/l) * creatinine ≤ 2.0 mg /dl * no indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation) * no contraindication to angiography or selective visceral catheterization * no history of severe allergy or intolerance to contrast agents, narcotics, sedatives. * negative serum pregnancy test * signed informed consent form exclusion criteria: * not meeting the inclusion criteria

Keywords: unresectable hepatocellular carcinoma radioembolization radiation segmentectomy